MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number	1012272-30
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The ironman guide wire referenced is being filed under a separate medwatch report.Evaluation summary: visual inspections was performed on the returned device.The shaft separation was confirmed.The reported difficulty removing the device from the guide wire could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported separation appears to be related to operational context; however, a conclusive cause for the reported difficulty removing the bdc from the guide wire could not be determined.It should be noted the coronary dilatation catheters, trek rx, instructions for use (ifu), states: the trek rx coronary dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right leg, below the knee.The 2.50x30mm rx trek was used to occlude the access site in the right foot.During removal of the device, the rx trek became stuck on the ironman guide wire therefore the devices were removed together.Outside the anatomy, during removal of the rx trek, the distal shaft separated and remained on the guide wire.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8371646
• Report Number: 2024168-2019-01479
• Device Sequence Number: 1203149
• Product Code: LOX
• UDI-Device Identifier: 08717648138324
• UDI-Public: 08717648138324
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 1012272-30
• Device Lot Number: 90102G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1